Clearance Summary
GUARDIAN FORCEP received FDA 510(k) clearance under submission number K893636, sponsored by Endo-Scientific, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-04-09.
- Submission: K893636
- Applicant / Sponsor: Endo-Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 1990-04-09
Classification & Regulation
This clearance is catalogued under FDA product code FCL and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.